A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Recruiting · NCT07219173 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
BrenipatidePlacebo
What this trial is about
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma. Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
- Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
- History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.
Exclusion criteria
- Participants are excluded from the study if any of the following criteria apply:
- An established diagnosis of occupational asthma
- Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
- chronic respiratory infection
- bronchiectasis
- pulmonary fibrosis
- allergic bronchopulmonary aspergillosis
- emphysema
- chronic bronchitis
- eosinophilic granulomatosis with polyangiitis
- chronic obstructive pulmonary disease, and
- other mimics of asthma, that is, vocal cord dysfunction.
- Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.
Where it is running
60 locations listed across 11 US states.
- AMR Clinical - Tempe, Arizona, United States
- NewportNativeMD, Inc. - Newport Beach, California, United States
- California Medical Research Associates - Northridge, California, United States
- Peninsula Research Associates - Rolling Hills Estates, California, United States
- Asthma & Allergy Associates - Colorado Springs - Colorado Springs, Colorado, United States
- AMR Clinical - Doral, Florida, United States
- Renstar Medical Research - Ocala, Florida, United States
- Avanza Medical Research Center - Pensacola, Florida, United States
- USF Health - Tampa, Florida, United States
- Axis Clinical Trials - Westchester - Westchester, Illinois, United States
- Allergy & Asthma Specialists, P.S.C. - Owensboro, Kentucky, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- AMR Clinical - Las Vegas, Nevada, United States
- Equity Medical - New York, New York, United States
- University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania, United States
- Allergy and Clinical Immunology Associates - Pittsburgh, Pennsylvania, United States
- Vanderbilt Asthma, Sinus and Allergy Program - Nashville, Tennessee, United States
- San Peregrino Unidad de Investigación - Aguascalientes, Mexico
- Centre Hospitalier du Pays dAix - Centre Hospitalier Intercommunal Aix-Pertuis - Site d'Aix en Provence - Aix-en-Provence, France
- Dynamic Drug Advancement - Ajax, Canada
- EB Medical Research - Almere Stad, Netherlands
- NewData Clinical Research - Aracaju - Aracaju, Brazil
- Galaxy Superspeciality Hospital - Aurangabad, India
- Mahatma Gandhi Mission Medical College - Aurangabad, India
- Medstar Speciality Hospital - Bangalore, India
- The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technolo -T - Baotou, China
- Beijing Chaoyang Hospital, Capital Medical University - Beijing, China
- KPPK Studienzentrum - Bendorf, Germany
- Studienpraxis Berlin-Brandenburg Lennart Schaper - Berlin, Germany
- All India Institute of Medical Sciences - Bhubaneswar, India
- Amphia Ziekenhuis, locatie Breda Molengracht - Breda, Netherlands
- CHRU de Brest - Brest, France
- Consultorios Médicos, Organización del Buen Ayre S.R.L. - Buenos Aires, Argentina
- Centro de Investigaciones Metabólicas (CINME) - Buenos Aires, Argentina
- Fundación Respirar - Buenos Aires, Argentina
- Heritage Medical Research Clinic - Calgary, Canada
- West China Hospital, Sichuan University - Chengdu, China
- Scientia Investigacion Clinica S.C. - Chihuahua City, Mexico
- Centre Hospitalier de Cholet - Cholet, France
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, China
- Tokyo-Eki Center-building Clinic - Chūōku, Japan
- IDIM - Instituto de Investigaciones Metabólicas - Ciudad de Buenos Aires, Argentina
- Instituto de Asma, Alergia y Enfermedades Respiratorias - Corrientes, Argentina
- Private Practice - Dr. Nelson Rosário - Curitiba, Brazil
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C. - Durango, Mexico
- Aakash Healthcare Private Limited - Dwārka, India
- Ambulantes Lungenzentrum Essen - Essen, Germany
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen - Essen, Germany
- IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardiovascul -T - Frankfurt, Germany
- Clinica de Pneumologia - Goiânia, Brazil
- Centro de Investigaciones Clínicas Baigorria - Granadero Baigorria, Argentina
- Instituto Jalisciense de Investigación Clínica Sa de Cv - Guadalajara, Mexico
- Clinica de Investigacion en Reumatologia y Obesidad S. C. - Guadalajara, Mexico
- Osaka Habikino Medical Center - Habikino, Japan
- ME Clinical Respiratory Research Hamburg - Hamburg, Germany
- St. Joseph's Healthcare Hamilton - Hamilton, Canada
- Zhejiang Provincial People's Hospital - Hangzhou, China
- Aso Iizuka Hospital - Iizuka, Japan
- Kagoshima University Hospital - Kagoshima, Japan
- Ishikawa Prefectural Central Hospital - Kanazawa, Japan
Showing 60 of 121 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →